Recall Z-1100-2013 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
GE Healthcare, Discovery MR750w 3.0T System. Part Number: 5352293. Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen,
| Date | Apr 11, 2013 (initiated Apr 23, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings. |
| Root cause | Software design |
| Action | GE Healthcare sent an Important Product Information letter dated April 23, 2012. The letter described the Issue, Instructions, Affected Product Details and Product Correction. For questions contact your local service representative. |
| Quantity | 46 |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, IL, MD, NJ, NY, OH, OK, TX. and the countries of Australia, Belarus, Canada, France, Germany, India, Japan, Lebanon, New Zealand, Saudi Arabia, Singapore, Spain, Sweden, Switzerland and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103327 | DISCOVERY MR750W 3.0T Ge Healthcare Japan Corporation, Sep 30, 2011 |